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Primary immunization of infants with an acellular pertussis vaccine in a double-blind randomized clinical trial
M Blennow1, M Granström, E Jäätmaa
1Department of Pediatrics, Karolinska Institute, Stockholm, Sweden.
Insights
A new acellular pertussis vaccine showed fewer adverse reactions and higher antibody responses in infants compared to whole-cell vaccines. This safer vaccine offers improved protection against pertussis.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Pertussis, a highly contagious respiratory infection, remains a significant public health concern globally.
- Whole-cell pertussis vaccines, while effective, are associated with a higher incidence of adverse reactions.
- Acellular pertussis vaccines aim to provide comparable efficacy with an improved safety profile.
Purpose of the Study:
- To evaluate the safety and immunogenicity of a two-component acellular pertussis vaccine.
- To compare the acellular vaccine's performance against a whole-cell pertussis vaccine and a placebo.
- To assess the vaccine's efficacy in primary immunization of infants.
Main Methods:
- A double-blind, randomized clinical trial involving 319 infants aged 6 months.
- Participants received either the acellular pertussis vaccine, whole-cell pertussis vaccine, or placebo.
- Adverse reactions (systemic and local) and antibody responses to pertussis toxin were monitored.
Main Results:
- The acellular vaccine group experienced significantly fewer and milder adverse reactions, including lower rates of fever and local redness.
- Fever (≥38°C) occurred in 6-8% of acellular vaccine recipients versus 25-37% of whole-cell vaccine recipients.
- Antibody response to pertussis toxin was achieved in 97-100% of infants receiving the acellular vaccine, compared to 59% with the whole-cell vaccine.
Conclusions:
- The two-component acellular pertussis vaccine demonstrates a favorable safety profile with reduced adverse reactions in infants.
- The acellular vaccine elicits a robust and superior antibody response compared to the whole-cell pertussis vaccine.
- This acellular pertussis vaccine represents a promising alternative for infant immunization, offering enhanced safety and immunogenicity.
Abstract:
The rate of adverse reactions and the immunogenicity of a two-component acellular pertussis vaccine as compared with a plain whole-cell vaccine and a placebo were evaluated for primary immunization in 319 6-month-old infants in a double-blind randomized clinical trial. The acellular vaccine produced few and mild systemic and local reactions. Fever (greater than or equal to 38 degrees C) occurred in 6% to 8% of acellular vaccinees as opposed to 25% to 37% of whole-cell vaccinees. Redness (greater than or equal to 1 cm) appeared in 2% to 13% of the acellular vaccine and 24% to 32% of the whole-cell vaccine recipients. Antibody response to pertussis toxin measured in a neutralization test was obtained in 97% to 100% of the infants receiving either two or three doses of the acellular vaccine as compared to 59% after three doses of whole-cell vaccine.